Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

Transfusional Hemosiderosis Clinical Trial

Official title:

International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394029
• Other study ID #: CICL670A2301
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: February 1, 2016
• Start date: July 2011
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyJordan: Ethical CommitteeEgypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Observational

Clinical Trial Summary

This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion Criteria:

• Patients with non-transfusional hemosiderosis

• Patients treated with deferasirox in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemosiderosis
• Transfusional Hemosiderosis

Intervention

Drug:
• deferasirox

Locations

Country	Name	City	State
Egypt	Novartis Investigative Site	Cairo
Egypt	Novartis Investigative Site	Cairo
Jordan	Novartis Investigative Site	Amman
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Oviedo	Asturias
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	West Midlands	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Egypt,  Jordan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Creatinine and liver enzyme levels	Observed over 3 years for each patient	3 years	Yes
Primary	Adverse Drug Reactions	Observed over 3 years for each patient	3 years	Yes